Postoperative PainPhase 3NCT05958589
Caudal Block for Inguinal Hernioplasty in Children
A Phase 3 study testing Caudal block with levobupivacaine, General anesthesia and Inguinal hernioplasty in people with Postoperative Pain, run by University of Novi Sad at 1 site in Serbia.
Trial summary
This is a prospective, randomized, controlled clinical study designed to determine the effectiveness of caudal block combined with general anesthesia in providing intra- and postoperative analgesia, and its effect on hemodynamic stability and drug consumption. Read more about this study
- Who is it for?
- Ages 3 to 5 years, men only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Caudal block with levobupivacaine, General anesthesia and Inguinal hernioplasty
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSerbia
- Study dates
- 8 Jan 2022to 20 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- boys between 3 to 5 years old
- scheduled for elective inguinal hernioplasty
- without comorbidities and chronic therapy, ASA class I
- body mass and growth normal for the given age
- no allergies
- no congenital anomalies and birth complications
Who cannot join
- emergency surgeries
- surgeries longer than 60 minutes
- acute infections with leucocytosis/leucopenia
- acute or chronic diseases
- deformities and disorders of spine and nervous system
- allergies
- pilonidal cyst and/or inflammation in sacral region
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Institute for health care of children and youth of Vojvodina
Novi Sad, Vojvodina, 21000
About this study
Official title: Efficacy and Safety of General Anesthesia With Caudal Block for Inguinal Hernioplasty in Children: a Randomized Controlled Trial
This is a prospective, randomized, controlled clinical study designed to determine the effectiveness of caudal block combined with general anesthesia in providing intra- and postoperative analgesia, and its effect on hemodynamic stability and drug consumption.
Read the detailed description
This prospective, randomized, controlled clinical study will include 70 boys aged 3-5 years scheduled for inguinal herniorrhaphy. Participants will be randomized in 1:1 ratio into two groups. The first group will receive general anesthesia for surgery, while the second group will receive general anesthesia in combination with caudal block. Postoperative pain, hemodynamic parameters and total consumption of all medicaments in the perioperative period will be monitored. Complications and side effects of drugs will be observed as well.
- Conditions
- Postoperative Pain
- Being tested
- Caudal block with levobupivacaine, General anesthesia, Inguinal hernioplasty
- Keywords
- general anesthesia, caudal block, pain, hemodynamic parameters
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal block with levobupivacaineDrug
After the introduction of general anesthesia, a single shot caudal block will be performed with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).
General anesthesiaDrug
On the day of operation all patients will recieve midazolam 0.5 mg/kg (maximum dose 15 mg) orally. Induction of anesthesia will be the same for all patients and consist of intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg). The airway will be obtained by placing a laryngeal mask (I-gel®).
Inguinal hernioplastyProcedure or surgery
Elective inguinal hernioplasty
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia + caudal block | Experimental | General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg), in combination with a single shot caudal block with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg). Receives: Drug: Caudal block with levobupivacaine; Drug: General anesthesia; Procedure: Inguinal hernioplasty |
| General anesthesia | Active comparator | General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg) Receives: Drug: General anesthesia; Procedure: Inguinal hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain level measured using the visual analog scale (VAS)
Measured: 5 hours
Postoperative pain
Postoperative pain level measured using the Wong-Baker Faces pain rating scale
Measured: 5 hours
Secondary outcomes (2)
Blood pressure
Noninvasive measurement of systolic and diastolic blood pressure
Measured: 5 hours
Heart rate
Heart rate measured with electrocardiogram
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start8 Jan 2022
- Primary completion20 Jul 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihaela Preveden, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958589
- Sponsor's protocol ID
- 05689/25-2
- Status last verified
- Dec 2024
- First submitted
- 7 Jul 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of General Anesthesia With Caudal Block for Inguinal Hernioplasty in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05958589
- Acronym / sponsor ID
- 05689/25-2
- Conditions
- Postoperative Pain
- Keywords
- general anesthesia, caudal block, pain, hemodynamic parameters
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, controlled clinical study designed to determine the effectiveness of caudal block combined with general anesthesia in providing intra- and postoperative analgesia, and its effect on hemodynamic stability and drug consumption.
Detailed description
This prospective, randomized, controlled clinical study will include 70 boys aged 3-5 years scheduled for inguinal herniorrhaphy. Participants will be randomized in 1:1 ratio into two groups. The first group will receive general anesthesia for surgery, while the second group will receive general anesthesia in combination with caudal block. Postoperative pain, hemodynamic parameters and total consumption of all medicaments in the perioperative period will be monitored. Complications and side effects of drugs will be observed as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia + caudal block | Experimental | Drug: Caudal block with levobupivacaine, Drug: General anesthesia, Procedure: Inguinal hernioplastyGeneral anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg), in combination with a single shot caudal block with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg). |
| General anesthesia | Active comparator | Drug: General anesthesia, Procedure: Inguinal hernioplastyGeneral anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg) |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- boys between 3 to 5 years old
- scheduled for elective inguinal hernioplasty
- without comorbidities and chronic therapy, ASA class I
- body mass and growth normal for the given age
- no allergies
Key exclusion criteria (7 listed)
- emergency surgeries
- surgeries longer than 60 minutes
- acute infections with leucocytosis/leucopenia
- acute or chronic diseases
- deformities and disorders of spine and nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caudal block with levobupivacaineAfter the introduction of general anesthesia, a single shot caudal block will be performed with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg). | Drug | General anesthesia + caudal block |
| General anesthesiaOn the day of operation all patients will recieve midazolam 0.5 mg/kg (maximum dose 15 mg) orally. Induction of anesthesia will be the same for all patients and consist of intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg). The airway will be obtained by placing a laryngeal mask (I-gel®). | Drug | General anesthesia, General anesthesia + caudal block |
| Inguinal hernioplastyElective inguinal hernioplasty | Procedure or surgery | General anesthesia, General anesthesia + caudal block |
Primary outcome
Postoperative pain
Time frame: 5 hours
Postoperative pain level measured using the visual analog scale (VAS)
Postoperative pain
Time frame: 5 hours
Postoperative pain level measured using the Wong-Baker Faces pain rating scale
2 secondary outcomes
Blood pressure
Time frame: 5 hours
Heart rate
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caudal block with levobupivacaine, General anesthesia and Inguinal hernioplasty in people with Postoperative Pain, run by University of Novi Sad at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.